Ineffective Drugs Being Approved By the FDA

​​​A new study published in JAMA Internal
Medicine
found that over the past five years, approximately two-thirds of cancer drugs
considered by the United States Food and Drug Administration (FDA) were
approved without proof they improved health outcomes or extended the length of
patients’ lives. Subsequent studies have shown that 86%
of the drugs approved with “surrogate endpoints” (or measures) and
approximately 57% of the cancer drugs approved by the FDA “have known effects
on overall survival or fail to show gains in survival.”

Afinitor has been approved by the FDA
five times in the past six years and has won approval for a new
use each time.
The drug is used to treat “breast and kidney
cancer, a rare type of pancreatic tumor and two types of nonmalignant tumors.” Since Afinitor was
first approved in 2009, and its subsequent expansion into the pool of potential
users, there have been almost 9,000 reports of serious adverse reactions,
including over 2,700 deaths and more than 3,100 hospitalizations. In the United
States, the sales rose drastically from $110 million in 2007 to $803 million in
2014. Afinitor, like other cancer drugs on the market, was approved for its
ability to slow the growth of tumors, which is considered a surrogate measure
of its effectiveness, rather than its ability to improve survival rates.

Surrogate measures also do not result
in lower drug prices once they are approved by the FDA. Rather, the drugs
approved by the FDA averaged around $10,000 per month. Four of these drugs cost
$20,000 per month and one even costs $40,000 per month. It seems
counterproductive to charge these exorbitant prices for drugs that have little
to no impact on the patient’s outcome. As a result of these studies, there are
questions as to whether the FDA is deeply entrenched in the influence of
pharmaceutical companies. As a correlation, the physicians unbiased prescribing
of the ineffective medication to their patients is called into question of
whether the pharmaceutical companies are placing undue influence on the
physicians through their pharmaceutical representatives.

Kate
Reynolds is currently a 2L at DePaul University College of Law. Ms. Reynolds
completed her undergraduate degree at the University of Illinois Springfield.
Ms. Reynolds wishes to pursue a career in Health Law after graduating in May of
2017.​​​